The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices and compatible non-medical components packaged together and placed on the market by NeuroXtherapeutics SA as convenience kit.The Procedure Pack is assembled to enable the use of the medical devices MindMotion GO and Izar for their intended medical purposes. It provides healthcare professionals with the necessary components required for installation and operation of the devices in clinical settings or at a patient’s home under professional supervision.The Procedure Pack does not create a new medical intended purpose and does not modify the intended purpose, performance, or classification of the individual medical devices included therein.
An assembly of devices intended to be used both in a home and clinical setting and to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back, trunk, and/or limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., patient-worn infrared (IR) glove, motion tracking heel pad or camera, software] that communicate to provide a virtual-display interface.
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